drugset / Trial / NCT00338962

Naltrexone & SSRI in Alcoholics With Depression/PTSD

NCT00338962

Phase 3 Completed 88 enrolled Yale University
RandomizedFactorialTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.

Timeline

Start
2001-10
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Desipramine Small molecule 200 mg
Comparator Naltrexone Small molecule 50 mg
Comparator Paroxetine Small molecule 40 mg